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Home Page2018-11-18T15:47:59+00:00

Hyperactivity of the immune system is a
life-threatening condition

In a normal immune response, macrophages and dendritic cells function as the body’s alarm system. These cells devour antigens and diseased or apoptotic cells and release alert signals called cytokines, which trigger the rest of the immune system into action. Once the threat has been eliminated, the immune system rebalances into a normal state.

Hyperactivity of the immune system, referred to as a cytokine storm or Cytokine Release Syndrome, is a systemic inflammatory response in which cytokine release spirals out of control, triggering severe immune attacks on multiple healthy organs, potentially leading to organ damage, multiple organ failure, and mortality. A cytokine storm can be triggered by a variety of factors, such as viral, bacterial and fungal infections.

Hyperactivity of the immune system,

Cytokine storms can’t be treated with traditional single-target drugs
This multifactorial problem involves dozens of cytokine types that induce multiple negative biological processes simultaneously, making it hard for traditional “one drug, one target” drugs to function properly. Treating Cytokine Release Syndrome requires major shifts in therapeutic paradigms, similar to several immunotherapies lately proven to address other complex indications.

Allocetra™ immune rebalancing

Allocetra™ is an innovative immunotherapy that is being developed to rebalance life-threatening hyperactivity of the immune system, using the immune system’s own natural regulation mechanisms. By intelligently engaging macrophages and dendritic cells, Allocetra™ is designed to avert cytokine storms and restores safe immune balance – without suppressing the immune system.

We put out storms

Rebalancing immune responses without suppressing the entire system

  • Cytokine StormCytokine Storm
  • Allocetra™ infusionAllocetra™ infusion
  • Macrophage feedingMacrophage feeding
  • Alert signals decreaseAlert signals decrease
  • Normal immune stateNormal immune state
  • a systemic inflammatory response in which cytokine release spirals out of control, triggering severe immune attacks on multiple healthy organs
  • Allocetra™, comprised of billions of densely concentrated semi-apoptotic (dying) cells, is infused into the patient’s blood stream.
  • Macrophages and dendritic cells, who, among other things, have the primary biological role to clear apoptotic cells from the body, feed on the infused cells.
  • While digesting the dying cells, macrophages and dendritic cells undergo a process of toleration, become less aggressive, and release fewer alert signals.
  • This results in lower expression of cytokines, rebalancing the system to its normal immune state.

Pipeline

pipeline

Prevention of complications post-bone marrow transplant

In a bone marrow transplant (BMT), healthy blood stem cells and white blood cells are infused into a patient’s body to replace damaged or diseased bone marrow and in many cases, to clear out the remainder of cancer cells in the patient’s system. BMTs may use cells from the patient’s own body (autologous transplant) or from a donor (allogeneic transplant).
An exaggerated immune response occurs when the donated white blood cells register the host body's tissues and organs as foreign antigens and attack them. This primary complication is termed Graft vs Host Disease, or GvHD. Upon the occurrence of GvHD, patients are typically treated with standard-of-care corticosteroids, antibodies, or small-molecules. Such treatment regimens are known in the scientific and medical communities to have poor efficacy profiles, as well as potentially compromising patients’ ability to respond to immunological challenges, or exposing patients to severe side effects, such as high blood pressure and eye disorders.

Allocetra™ is being developed to prevent life-threatening post-transplantation complications, without exposing patients to the risk of infection.

Treatment of post-BMT complications for steroid refractory patients

Some patients, who develop severe GvHD post-BMT, do not respond to corticosteroids, and have a dire mortality rate of up to 90% within the first 12 months post-BMT. Severe GvHD involves a cytokine storm that may lead to multiple organ failure and potential death.

Allocetra™ is being developed to effectively treat steroid-refractory GvHD patients for whom survival forecast is bleak.

Treatment of Sepsis

While 55% of Americans have never heard of sepsis, it is the #3 cause of mortality in the United States. It is categorized as the body’s overwhelming, life-threatening response to an infection or inflammation. It can potentially lead to tissue damage, organ failure, and death. In many sepsis cases, at the same time that the medical team is administering the best standard of care, mainly antibiotics and fluids, a cytokine storm occurs. Such hyper-immune activity may result in an attack of immune killer cells (e.g., T-cells, B-cells, natural killer cells) on healthy organs of the patient, such as the heart, brain, lungs, liver, kidneys, and others. This attack may lead to organ damage, multiple organ failure, and death.

Allocetra™ is being developed for the prevention of organ failure and mortality in patients with sepsis, offering a novel immunotherapeutic treatment approach to solve one of healthcare’s most acute challenges.

Solid tumor “immune checkpoint” microenvironment modulating

While first-generation immuno-oncology therapies for non-solid tumors, such as checkpoint inhibitors and CAR-T procedures, present a remarkable therapeutic advance, solid tumors are harder to treat, primarily due to the complex and interconnected tumor microenvironment (TME). Enlivex had discovered a proprietary “immune checkpoint” pathway for solid tumors, which is activated by the engulfment of Allocetra™.

Allocetra™ is being developed as an adjunctive “immune checkpoint” therapy in combination with CAR-T, TCRs, and other any solid cancer agents.

We wish to save lives everywhere,
by promoting the immuno-balance paradigm

Our mission is to establish new equilibriums – both in patients’ immune responses and in the field of immunotherapy.

As a clinical-stage company focused on specialized cell immunotherapy, we intend to develop and commercialize an allogeneic drug pipeline designed to rebalance all manner of immune hyper responses.

Our pioneering Allocetra™ cell-based therapy breaks with old paradigms, offering to effectively treat numerous acute conditions through a radically different clinical approach. By using the body’s native mechanisms to restore – rather than suppress – immune balance, we aim to reshape the way immune, autoimmune, and inflammatory conditions are both thought of and treated.

Advanced clinical-stage pipeline

Advanced clinical-stage pipeline
with promising Phase II results

Short regulatory approval pathway

Short regulatory approval pathway
FDA & EU orphan designations; Specialized Life-Threatening Regulation in Europe potentially enables post-Phase II marketing approval

Multi-billion-dollar markets

Multi-billion-dollar markets
BMT, Sepsis, Solid tumors

Strong leadership,
inspired by great science and a sense of mission

Our management, scientific advisors, personnel, and affiliates have gained extensive knowledge in the treatment of immune and inflammatory disorders, and expertise in the research and development of therapies based on apoptotic cell clearance.

Shai Novik

Executive Chairman

Founder of Prolor Biotech, Sold in 2013 ($560mm transaction). Lead product partnered to Pfizer, $295 million down payment, $275 upon FDA approval

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Prof. Dror Mevorach, M.D.

Chief Scientific & Medical Officer

Director, Rheumatology Research Centre and Molecular Immunology; and Director, Centre for Rare diseases, Hadassah Medical Center, Jerusalem

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Shmuel Hess, Ph.D.

Chief Executive Officer

Former CEO of Valin Technologies, generated multimillion $ revenues in revenues from partnering agreements

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Bernhard Kirschbaum, Ph.D.

Director

Former Executive Vice President & Member of the Board at Merck Serono, Head of Global Research & Early Development

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Abraham Havron, Ph.D.

Director

CEO of PROLOR Biotech 2005-2013

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Sangwoo Lee

Director

Executive Director of the Investment Department & Head of U.S. Branch at Korea Investment Partners Co. Ltd

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Hyun Gyu Lee, Ph.D., M.D.

Director

Executive Director, Investment Division, Korea Investment Partners Co., Ltd

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Gili Hart, Ph.D.

Director

CEO of Mitoconix Ltd., a company focused on development of Mitochondria-related therapies

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Baruch Halpert

Director

Over 20 years of experience in VC and Private Equity as an entrepreneur, corporate finance advisor, senior executive and an investor

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Michel Habib

Director

Managing Partner of Agate-MaC Fund, a healthcare VC

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Find out more

POB 12167, Hadassah Ein Kerem, Jerusalem 91121, Israel,
T +972.2.6708072 | F +972.2.6708070
info@enlivex.com